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Methods Prospective (methods + prospective)

Distribution by Scientific Domains

Medical Sciences	100%

Selected Abstracts

Insulin aspart vs. human insulin in the management of long-term blood glucose control in Type 1 diabetes mellitus: a randomized controlled trial

DIABETIC MEDICINE, Issue 11 2000
P. D. Home
SUMMARY Aims To compare the efficacy of insulin aspart, a rapid-acting insulin analogue, with that of unmodified human insulin on long-term blood glucose control in Type 1 diabetes mellitus. Methods Prospective, multi-centre, randomized, open-labelled, parallel-group trial lasting 6 months in 88 centres in eight European countries and including 1070 adult subjects with Type 1 diabetes. Study patients were randomized 2:1 to insulin aspart or unmodified human insulin before main meals, with NPH-insulin as basal insulin. Main outcome measures were blood glucose control as assessed by HbA1c, eight-point self-monitored blood glucose profiles, insulin dose, quality of life, hypoglycaemia, and adverse events. Results After 6 months, insulin aspart was superior to human insulin with respect to HbA1c with a baseline-adjusted difference in HbA1c of 0.12 (95% confidence interval 0.03,0.22) %Hb, P < 0.02. Eight-point blood glucose profiles showed lower post-prandial glucose levels (mean baseline-adjusted ,0.6 to ,1.2 mmol/l, P < 0.01) after all main meals, but higher pre-prandial glucose levels before breakfast and dinner (0.7,0.8 mmol/l, P < 0.01) with insulin aspart. Satisfaction with treatment was significantly better in patients treated with insulin aspart (WHO Diabetes Treatment Satisfaction Questionnaire (DTSQ) baseline-adjusted difference 2.3 (1.2,3.3) points, P < 0.001). The relative risk of experiencing a major hypoglycaemic episode with insulin aspart compared to human insulin was 0.83 (0.59,1.18, NS). Major night hypoglycaemic events requiring parenteral treatment were less with insulin aspart (1.3 vs. 3.4% of patients, P < 0.05), as were late post-prandial (4,6 h) events (1.8 vs. 5.0% of patients, P < 0.005). Conclusions These results show small but useful advantage for the rapid-acting insulin analogue insulin aspart as a tool to improve long-term blood glucose control, hypoglycaemia, and quality of life, in people with Type 1 diabetes mellitus. [source]

Gastroesophageal Reflux and Obstructive Sleep Apnea,

THE LARYNGOSCOPE, Issue 12 2001
Brent A. Senior MD
Abstract Objective To determine the extent to which gastroesophageal reflux (GER)-initiated laryngeal chemoreflexes contribute to obstructive sleep apnea (OSA). Methods Prospective, nonrandomized clinical trial of an antireflux treatment protocol as a means of reducing the severity of OSA. Population consisted of 10 males aged 20 to 64 years with confirmed OSA (by overnight polysomnography) and GER (by ambulatory pH probe monitoring). Patients were treated with omeprazole and standard antireflux protocol for 30 days and pre- and posttreatment polysomnography variables were compared. Results Mean apnea index declined 31% (45,31, P = .04); mean respiratory disturbance index declined 25% (62,46, P = .06). Three patients (30%) are "treatment responders" as defined by traditional OSA treatment definitions. Conclusions These results suggest a potential relationship between OSA and GER, the treatment of which may be an effective adjunctive in those with both disorders. Treatment of GER may significantly impact OSA in select individuals. [source]

4263: Observation in choroidal melanomas

ACTA OPHTHALMOLOGICA, Issue 2010
C GARCIA-ALVAREZ
Purpose The management of suspected small choroidal melanomas is controversial. The purpose of the present study is to assess tumor growth, visual acuity changes, activity factors and survival on choroidal melanoma patients under observation in our Intraocular Tumors Unit. Methods Prospective, consecutive and non-interventional case series. Patients diagnosed with choroidal melanoma from 1990 to 2010 and with observation as therapeutic option were included. Criteria for observation were small size without risk factors for growing; medium and large size: no risk factors for growing (but size), advanced age, bad general health, only eye or treatment rejection. Demographic, tumoral and follow-up data were collected in a data base and analyzed. Results 118 out of 397 patients (29.7%) diagnosed with uveal melanoma were enrolled, with mean age of 66.4 years (SD 14.3). The mean follow-up time was 51.1 months (SD 4.5). Regarding the size, 91 (77.1%) tumors were small and 85 (72.%) were diagnosed in a routine examination. Main reason for observation was tumor small/inactive (80,5%) followed by treatment rejection (17.7%). Mean height was 2.8mm (SD 1.9) and mean base 7.6 (SD 2.8). Along the follow-up, 17 tumors grew; 11 were treated with brachytherapy, 5 with enucleation and one with brachytherapy and enucleation. Only 16 patients died during the follow-up, 2 by melanoma metastasis. Conclusion In our series with more than 4 years of follow up, observation seems to be a safe therapeutic option for selected small choroidal melanomas, allowing the patients to preserve visual function. [source]

2144: LASEK with MMC vs femtosecond sub-Bowmann keratomileusis to correct myopic astigmatism: a pilot study

ACTA OPHTHALMOLOGICA, Issue 2010
MA TEUS
Purpose To evaluate the safety and efficacy of LASEK and Femtosecond sub-Bowmann Keratomileusis (FSBK) in the correction of myopic astigmatism Methods Prospective, masked study of consecutive eyes, with myopic astigmatism higher than 1.5D. MMC was used in LASEK eyes if ablation > 50 microns. Visual results were evaluated three months post-op Results 252 eyes were analyzed, 125 LASEK and 127 FSBK. Preoperative sphere and cylinder was similar in both groups (p=0.1). Safety and Efficacy indexes were 1.01 vs 1.02 and 0.90 vs 0.88 in LASEK and FSBK groups, respectively (p=0.8 and 0.3) Conclusion LASEK and FSBK achieve comparable visual results when used to correct myopic astigmatism at 3 months follow-up [source]